Perrigo unit asks FDA to approve first ever over-the-counter birth control pill

Perrigo unit asks FDA to approve first ever over-the-counter birth control pill


A pharmacist holds the compound PiDaNa of the company HRA Pharma in Hamburg, Germany.

Daniel Reinhardt | Picture Alliance | Getty Images

Perrigo Company said on Monday its unit HRA Pharma has asked the U.S. Food and Drug Administration to approve a daily birth control pill for over-the-counter sale, the first such request for this type of contraception. The application from the HRA comes on the back of the U.S. Supreme Court’s decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide.

The contraceptive is currently a prescription drug sold under brand Opill.

HRA Pharma expects the regulator to hold an advisory committee meeting and approve the application in the first half of 2023, a period of about 10 months is typical for such approval requests, said Frédérique Welgryn, HRA Pharma’s chief strategic operations and innovation officer.

“The timing is a bit coincidental. We have been working on that application for the last seven years,” Welgryn said.

The FDA declined to comment on the submission.

Meanwhile, Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists, said the submission was a positive.

“We know that birth control is not a solution to abortion bans, as people need abortion care for many reasons,” Hoskins said, but added that the pill could still help more people to “control their own reproductive futures”.

Currently, the only contraception drugs available for women without a prescription are emergency oral pills that can be taken within three days after having unprotected sex.

Abortion rights activists have stepped up calls to make mifepristone, which in combination with misoprostol induces an abortion up to 10 weeks into a pregnancy, available OTC.

The non-estrogen Opill has been used with prescription since it was FDA-approved in 1973. Perrigo said scientific evidence has shown progestin-only pills, such as Opill, are effective at preventing pregnancy and safe for most women to use.



Source

A world on weight loss drugs: How GLP-1s are reshaping the economy
Health

A world on weight loss drugs: How GLP-1s are reshaping the economy

Eternalcreative | Istock | Getty Images Miracle drugs, obesity treatments and skinny jabs. Call them what you will, few drugs have had a more transformative effect on Wall Street and waistlines over recent decades than GLP-1s. Familiarly known under the brand names Wegovy and Zepbound, Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of medication used to […]

Read More
Eli Lilly’s obesity pill remains a viable rival to Novo’s oral Wegovy despite data that underwhelmed investors
Health

Eli Lilly’s obesity pill remains a viable rival to Novo’s oral Wegovy despite data that underwhelmed investors

A sign with the company logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024. Scott Olson | Getty Images Eli Lilly‘s stock is still recovering after the drugmaker released trial data earlier this month on its closely watched obesity pill that underwhelmed Wall Street. In a key late-stage trial, […]

Read More
Supreme Court allows Trump’s cuts to health research grants over DEI policies
Health

Supreme Court allows Trump’s cuts to health research grants over DEI policies

The Supreme Court on Thursday allowed Trump administration broad cuts to National Institutes of Health grants as part of the federal government’s campaign against diversity, equity and inclusion policies. But in a mixed decision the court left in place a different part of the lower court judge’s ruling that threw out the administration’s guidance document that introduced the policy, […]

Read More